Low Profile Titanium Model Catalog #1003

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K953073 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Arrow Intl., Inc. →

• What is the LOW PROFILE TITANIUM MODEL CATALOG #1003 used for?

  The LOW PROFILE TITANIUM MODEL CATALOG #1003 is a medical device intended for vascular access procedures, specifically as an implanted subcutaneous intravascular port and catheter system to provide long-term access to the bloodstream for therapies such as chemotherapy, parenteral nutrition, or blood draws.

• How is the LOW PROFILE TITANIUM MODEL CATALOG #1003 supplied and is it sterile?

  The device is supplied as a sterile, single-use implanted system; while the data does not explicitly state sterility or single-use status, its classification as an implanted port and catheter under FDA 510(k) clearance implies it is intended for sterile, single-patient use during implantation, consistent with standard vascular access device protocols.

• What regulatory pathway was used for the LOW PROFILE TITANIUM MODEL CATALOG #1003?

  The device received FDA 510(k) clearance under submission K953073 on September 19, 1995, indicating it was found substantially equivalent to a legally marketed predicate device, which is the standard regulatory route for moderate-risk Class II medical devices like this port and catheter system.